Team-NB Releases High-Level Position on the Regulatory Framework for the Medical Devices Sector Team NB, has published its high level position on the regulatory framework for the medical devices sector. Team-NB Releases High-Level Position on the Regulatory Framework for the Medical Devices Sector
MDCG 2024-15 – Guidance on Publication of Clinical Investigation Reports and Summaries in Absence of EUDAMED The Medical Device Coordination Group (MDCG) 2024-15 Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED has been published. MDCG 2024-15 – Guidance on Publication of Clinical Investigation Reports and Summaries in Absence of EUDAMED
MHRA AI Airlock Pilot Scheme Technologies MHRA has published the first five technologies as part of the AI Airlock sandbox. MHRA AI Airlock Pilot Scheme Technologies
European Commission Webinar on Packaging and Packaging Waste Regulation On 16 December, the European Commission is hosting a webinar on the Packaging and Packaging Waste Regulation (PPWR). European Commission Webinar on Packaging and Packaging Waste Regulation
Team NB Releases Questionnaire on Artificial Intelligence in Medical Devices Team-NB has published a questionnaire on artificial intelligence in medical devices. Team NB Releases Questionnaire on Artificial Intelligence in Medical Devices
MHRA Windsor Framework and Established Medicines Webinar Recordings MHRA has published recordings on recent webinars on the topics of Windsor Framework and Established Medicines. MHRA Windsor Framework and Established Medicines Webinar Recordings
Planned Meetings of MDCG and Subgroups in 2025 Published The EC has released the 2025 meeting schedule for MDCG and its subgroups. Planned Meetings of MDCG and Subgroups in 2025 Published
New MHRA Chair: Anthony Harnden Appointed MHRA has elected a new chair. New MHRA Chair: Anthony Harnden Appointed
MHRA Future Medical Device Regulations Consultation MHRA has launched a public consultation to seek views on proposals to update four areas of the future regulatory framework for medical devices and in vitro diagnostic (IVD) devices. MHRA Future Medical Device Regulations Consultation
MHRA Publishes Statement of Policy Intent: Relaunch of ILAP The new ILAP will open to applications in March 2025, with full details of the pathway to be published in January 2025. MHRA Publishes Statement of Policy Intent: Relaunch of ILAP
Q&A on Practical Guidance for Implementing Notification Obligations for Supply Interruptions or Discontinuations of Certain Devices Published The European Commission has released a Q&A document detailing guidance on fulfilling notification obligations for supply interruptions or discontinuations of certain devices, as required under the MDR and IVDR. Q&A on Practical Guidance for Implementing Notification Obligations for Supply Interruptions or Discontinuations of Certain Devices Published
AESGP Webinar – Online Trade of Consumer Healthcare Products AESGP is hosting a webinar, 'Online Trade of Consumer Healthcare Products under the EU’s Digital Markets Act and Digital Services Act', on Tuesday 3 December, from 11.30 to 13.00 (GMT). AESGP Webinar – Online Trade of Consumer Healthcare Products
